Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria
This is a phase 2a, randomised, double-blind, placebo-controlled, cross-over trial conducted in Germany at 3-6 sites. Subjects will be randomised to one of two treatment sequences (A and B). Each treatment period will last 7 days with a wash-out period of 7 days between treatments. Half of the subjects will start with treatment A followed by treatment B while the other half will start with treatment B followed by treatment A. A safety follow-up visit will be performed 3 days after last dose of the tested medication. The main assessment is an urticaria activity score. After a Pulse-controlled ergometry (PCE) provocation test subjects will be rated on their number of wheals and their itch severity, resulting in a sum score ranging from 0 to 6 points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
LEO 152020 is a small drug molecule which can block the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.
LEO Investigational Site
Aachen, Germany
LEO Investigational Site
Berlin, Germany
LEO Investigational Site
Dresden, Germany
LEO Investigational Site
Freiburg im Breisgau, Germany
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)
The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating.
Time frame: Baseline to Day 7
Number of Treatment Emergent Adverse Events
Time frame: From start of each treatment period (day 1 for the 1st treatment period or day 15 or 22 for the 2nd treatment period) until 3 days after end of each treatment period (day 11 for the 1st treatment period or day 25 or 32 for the 2nd treatment period)
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LEO Investigational Site
Kiel, Germany
LEO Investigational Site
München, Germany